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B -- REGULATORY STUDY SOL NLM 98-083/LTN DUE 081398 POC Liem T. Nguyen, Contract Specialist, 301-496-6546 The National Institutes of Health (NIH) intends to fund follow-on work performed by Mr. John Mahoney, Brinklow, Maryland, to further study and prepare a report on "Review of Regulatory Burden." The House Appropriations Committee, in its report accompanying the FY 1998 Appropriations Bill, requested that NIH provide a report on Federal regulations that are considered to be unnecessarily burdensome by Universities and their research scientists. While acknowledging the necessity of Federal regulations in the oversight and conduct of Federally sponsored research, the Committee seeks suggestions for "rationalizing and reducing" this regulatory burden. Although the report language included a request to provide an inventory of regulations and mandates, and an estimate of their costs, the NIH subsequently requested a modification to broaden the view from financial costs to other forms of burden such as investigator effort, administrator burden, and the atmosphere affecting research. The NIH pointed out that there are several categories of regulations: (1) some that are specifically focused on research activities and are, at least to some extent, within the control of the Department of Health and Human Services (DHHS); (2) some that have burdensome elements and apply to researchers, but where control is located outside the NIH and where the scope is broader than research; and (3) some that may affect research, but the intended scope is far broader, and it is unlikely that the impact on research would be a basis for change in regulation. The NIH suggested that the greatest return would come from examining the first group of regulations. The Committee agrees with this direction, including moving toward recommendations for change without quantifying the burden. The agreed-upon areas of focus include human subjects protections, animal welfare regulations, conflict of interest, biohazard (other than radiation), and misconduct. The suggested approach is to assess whether burden derives from the regulation per se or fromthe process of implementation. Additionally, NIH will also address the extent to which the second group of regulations is perceived to impede research, and make recommendations for change. This study will be undertaken in two phases. The first will be to identify those aspects of regulations, whether it be the regulations themselves, or their implementation, in the areas mentioned above that are perceived by the research community to be unnecessarily burdensome. The second phase will be the identification of solutions or alternatives that may be appropriate to resolve the unnecessary burden that may exist. The Committee urged that this study be carried out in a similar fashion to the research management and support study that was previously completed by Mr. John Mahoney. Mr. Mahoney previously worked at NIH and therefore requires no extensive orientation to NIH functions and operations. Moreover, his previous position at NIH as its chief administrative manager gives him a unique understanding of business processes, governmental regulations, and statutory stewardship of Federal research funds. Mr. Mahoney also had experience in directing the recent similar study on NIH research management support. The studies are very similar in their attention to management and business practices, the concept of best practices, and the differences between necessary and ancillary functions and processes. An understanding of the complexities of the previous study provides Mr. Mahoney with a unique background and perspective. In addition, Mr. Mahoney's previous experience with the Congressionally mandated research management and support study also gives him a unique understanding of Congressional needs in such a study and subsequent reporting. NIH has determined that Mr. John Mahoney is the only source with the unique combination of required expertise and experience who can successfully complete the study and subsequently prepare a written report identifying those regulations that are best candidates for streamlining. It is anticipated that not-to-exceed 990 hours will be devoted to this effort over a period of 12 months. This is a notice of intent and not a Request for Quotations (RFQ), nor is an RFQ available. ***** Posted 07/28/98 (W-SN229285). (0209)

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